Nasal implant introduced through a non-surgical injection technique

ABSTRACT

A method for non-surgically treating an internal nasal valve of a patient comprising, injecting a working device into the internal nasal valve of the patient, wherein the injected working device in the nasal tissue causes an alteration of an internal or external nasal valve. A device introduced by injection into the nose, allowing for structural support or filling of defects in the nose, and causing a change in external shape of the nose. The device and inserts and implants described also have use in cosmetic applications relating to the facial tissue.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a Division of application Ser. No. 11/898,768, filedSep. 14, 2007, which claims the benefit of U.S. Provisional ApplicationNo. 60/846,736, filed Sep. 25, 2006. The entire disclosure of theseprior applications is hereby incorporated by reference.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

This invention has been created without the sponsorship or funding ofany federally sponsored research or development program.

SEQUENCE LISTING OR PROGRAMS

Not Applicable

FIELD OF THE INVENTION

The invention relates to methods, implants, and devices fornon-surgically supporting the nasal valve, and achieving cosmeticchanges to the shape of the nose (e.g., rhinoplasty). The device isintroduced through an injectable method into the nasal tissue, and byspecially designed suture.

BACKGROUND OF THE INVENTION

The information provided below is not admitted to be prior art to thepresent invention, but is provided solely to assist the understanding ofthe reader.

The internal nasal valve is the narrowest point in the nasal airway andis the point that often limits inspiration flow. A large percentage ofinspiratory resistance is attributable to internal nasal valve functionor malfunction. Collapse of one or both internal nasal valves is acommon cause of nasal airway obstruction. Narrowness of the nasal valvemay lead to difficulty in respiration and snoring as well as otherbreathing related disorders such as sleep apnea. Internal nasal valvecollapse can be a consequence of previous surgery, trauma, aging, orprimary weakness of the upper or lower lateral cartilage and is oftensymptomatic and debilitating.

A description of the nasal valve and its functions are more fullydescribed in Cole, “The Four Components of the Nasal Valve”, AmericanJournal of Rhinology, Vol. 17, No. 2, pp. 107-110 (2003). See also,Cole, “Biophysics of Nasal Air Flow: A Review”, American Journal ofRhhinology, Vol. 14, No. 4, pp. 245-249 (2000).

Surgery to strengthen the nasal valve has been shown to significantlyimprove quality of life for treated patients. Rhee, et al., “Nasal ValveSurgery Improves Disease—Specific Quality of Life”, Laryngoscope, Vol.115, pp. 437-440 (2005). The most common procedure for treating nasalvalve collapse is the so-called alar batten grafting. In battengrafting, a patient's cartilage is harvested from any one of a number oflocations such as the nasal septum or the ear. The cartilage is sculptedto an appropriate size and shaped and beveled on the edges for improvedcosmetics. The batten graft is placed in the desired location of thenasal passage through either an external or endonasal approach. A pocketis formed overlying the cartilages of the nose with the pocket sized toreceive the batten graft. Placement of the batten graft is shown in FIG.4 (page 577) of Millman, et al., “Alar Batten Grafting for Management ofthe Collapsed Nasal Valve”, Laryngoscope, Vol. 112, pp. 574-579 (2002).Other nasal valve surgeries are described in Kalan, et al., “Treatmentof External Nasal Valve (Alar Rim) Collapse with an Alar Strut”, Journalof Laryngology and Otology, Vol. 115, pages 788-791 (2001); Karen, etal., “The Use of Percutaneous Sutures for Graft Fixation inRhinoplasty”, Archives Facial Plastic Surgery, Vol. 5, pp. 193-196(2003) and Fanous, “Collapsed Nasal-Valve Widening by Composite Graftingto the Nasal Floor”, Journal of Otolaryngology, Vol. 25, No. 5, pp.313-316 (1996).

The harvesting of a portion of the patient's natural cartilage is anadditional procedure and requires sculpting or other modification of thegraft prior to use. Accordingly, surgically implanted synthetic nasaldilators, and non-surgical external dilators and cones have beensuggested. An example of a surgically implanted dilator is found in U.S.Pat. No. 6,106,541 to Hurbis dated Aug. 22, 2000. In the '541 patent,the nasal dilator has a V-shape with an apex placed over the bridge ofthe nose to support the nasal tissue at the area of the internal valve.Other examples include U.S. Pat. No. 6,322,590 to Sillers et al., datedNov. 27, 2001. However, use of such devices require an open surgicaltechnique for insertion.

External (non-implanted) nasal dilators which are placed temporarily,and are removed by the patient are also available. Such external devicesare possibly placed on the outside surface of the nose such as the“Breathe Right strips, U.S. Pat. No. 5,533,440, or U.S. Pat. No.7,114,495 by Lockwood. Other devices may be placed in the nasal cavity(but not implanted in the nose), such as U.S. Pat. No. 7,055,523 givento Brown, and U.S. Pat. No. 6,978,781 given to Jordan. However, suchdevices can be uncomfortable, unsightly, and require the patient toremove and replace the device on a periodic basis.

Therefore, there is an urgent need for identifying methods and systemsfor repairing nasal valves and related nasal structures, including therepairing of the internal nasal valve collapse, which would eliminatethe need for invasive surgical techniques. And thus eliminating risksand costs of general anesthesia and operating room expenses, and shortenrecovery periods. It is also desirable to identify methods and systemsthat are implanted within the nose, eliminating the need for disposableexternal devices

Unlike previous implant methods known and described, the implant of thisinvention is inserted by means of an injection technique, and does notrequire surgical incisions. It is inserted percutaneously ortransmucosally, usually under local anesthetic only. The implant mayhave different shapes and/or physical properties than previous implantsdescribed. This allows for it to be inserted by means of a non surgicaltechnique, and the position may be adjusted initially after placement.One aspect of the invention would permit the implant to be adjustedafter implantation

Unlike previous nasal strips and dilators, the current inventionprovides a device and means whereby the device(s) is embedded within thetissue of the nose. It is designed to be permanent or long lasting. Itis not visible externally, and does not require the replacement or theadjustment by the patient and/or the physician.

BRIEF SUMMARY OF THE INVENTION

Objects of the present invention include providing a method and systemfor treating internal nasal valve collapse. According to the presentinvention, this is achieved by non-surgical or minimally invasivetreatment. Treatment of the internal nasal valve includes injecting aworking implant into the tissue of the patient, affecting the internalnasal valve of the patient. The injection of the implant of thisinvention into the tissue surrounding internal nasal valve, according tothe invention, causes an alteration or a change in the internal nasalvalve angle.

In certain embodiments, the increase in internal nasal valve angle isaffected by the working device which causes an increase in thestructural strength of the tissue surrounding the nasal valve, thuspreventing the tissue from collapsing during inspiration.

In another embodiment, the working device is injected into more lateralstructures of the nose which causes adjustment of the position of thelateral aspect of the lateral nasal cartilage whereby affecting theexternal nasal valve.

In another embodiment, the working device is injected into more lateralstructures of the nose, strengthening the lateral nasal cartilage,supporting the external nasal valve, and preventing collapse duringinspiration.

In another embodiment, the working device is injected into more lateralstructures of the nose, strengthening the attachments of lateral nasalcartilage to the bone adjacent to the piriform aperture, and supportingthe external nasal valve, and preventing collapse during inspiration.

In another embodiment, the treatment method includes inserting animplant adjacent to lower lateral cartilage, the nasal dorsum, theparamedian tissue of the nasal dorsum, or the collumella to change theexternal shape of the nose.

In another embodiment, the implant is cylindrical in shape, though othershapes have also been described and fall within the scope of the presentinvention. The size is selected such that the implant can fit in thecore of a needle (similar to a hypodermic needle). It is introduced intothe nasal tissue by inserting the needle into the desired location. Theimplant is then maintained in that position by application of gentlepressure on the implant by an advancement shaft as the needle iswithdrawn.

In another embodiment the implant has variable physical properties,depending on the particular application. Implants may have a rigid orflexible shape or configuration. The insert may be moldable such thatthe shape is changed and maintained just before or after implantation,or later modified as desired by the patient or as needed to obtain theresults desired. Furthermore, implants can have shape-memory, with atendency to return to its preset shape when deflected.

In another embodiment of the invention, the invention relates to aninjection device for introducing the implant, which comprises of anintroduction needle containing the implant.

In another embodiment the implant may have sutures attached at either orboth ends, and a separate guiding needle attached to at least one end ofone of the sutures. This needle may be passed along the desired path ofthe implant. The attached sutures can then be used to guide theimplantation of the implant, and to adjust position in the tissueimmediately after implantation. These sutures may then be trimmed asneeded.

The treatment method, according to embodiments of the invention, may beused to treat, nasal snoring, sleep apnea, and/or internal nasal valvecollapse.

In another embodiment, a system for non-surgically treating the nasalvalves of a patient or changing the shape of the nose includes anintroducing needle, an implant present within the needle, an advancementshaft, and a handle portion. In certain embodiments of the invention,there may be a stop element to possibly control the movement of theadvancement shaft after the introduction needle containing the implantis placed in the desired location.

In another embodiment, the system includes a pre-loaded syringe with aworking device. In one embodiment, the working device is comprising asolid or a semi-solid material, or a hollow or a non-hollow cylinder ofmaterial. In another embodiment, the working device is comprising awoven mesh of material, biodegradable material, or a combinationthereof.

In certain embodiments, the nasal implant proposed is an implantintroduced into the nose through an injection technique, eithertransmucosally from inside the nose, or transcutaneously, from outsidethe nose.

The implant of the present invention is intended for insertion into thenose tissue and serves to augment or modify the structure of the noseand the nasal or flow passages. The implant provides support of nasalvalves in the nose and may serve to fill defects and/or supplement ormodify the contour of the nose in the manner desired for the purpose.

The implant is introduced into a desired location within the nose ornasal passageway using an injection method. The implant is firstincorporated into an injection device. The injection device may includea stop mechanism which serves to indicate when the implant is fullyimplanted.

The implant may be of any appropriate shape, including a cylindrical, anoval, or a rectangular and may include one or more tapered ends

The implant of the present invention may be malleable, which wouldpermit the shape of the implant to be adjusted before or afterimplantation. While not required, it may be preferred to use an implantmade of a material which has shape memory properties. This propertywould permit the shape memory properties to be activated, or adjustedafter implantation with the application of an external condition, suchas temperature, magnetic field, or light.

In another embodiments of the invention, the implant may have springlike properties.

In another embodiments of the invention, the implant may be manufacturedfrom a solid material, a composite of materials and may be a singlematerial or may be a composite of one or more materials. The implant maybe in the form of a rod or rod-like structure or may have a woven orbraided structure. The implant may be woven or braided with severalmaterials. In addition, the implant may be manufactured withbiodegradable materials, including those with shape memory.

The implant may be introduced or injected through a transmucosal ortranscutaneous route. The implant may be implanted within soft tissue ofthe nose in a location appropriate to provide the desired effect orresult. When implanted into the soft tissue of the nose, the implant mayserve to support the soft tissue relative to the underlying bonestructure. Further, the implant may be used to augment the lower lateralcartilages of the nose. In another aspect of the invention the implantmay be placed in the nose superior or inferior to the nasal cartilage.Further it may be placed in a manner which will serve to augment thedorsum of the nose, or the collumella and may additionally be placed ina paramedian location in the nose.

In another embodiment, the implant along with the inserting device andmay be altered to be used in other areas of the body such as, but notlimited to, naso-labial folds, lips, and marrienette lines.

One embodiment of the invention is to provide a non-surgical approachfor treating and eliminating these cosmetic conditions whether relatedto nasal valve problems or any other cosmetic related conditions.

The implant may be introduced into the desired location using a pullthrough technique, a guiding needle, or a combination of suchtechniques. The implant may be provided separately or with an injectiondevice Where desired the implant may incorporate a special pull throughsuture. The implant may additionally include a trailing suture. Where apull through needle or trailing suture is used, both may be made ormanufactured using materials which are dissolvable after the implantprocess is completed.

DESCRIPTION OF THE FIGURES

FIG. 1 is a perspective view of the front, top and left side of apatient's nose showing skeletal components and cartilages. Labeled arethe Nose (N). Nasal bone (NB), Left upper cartilage (LUC), Right upperlateral cartilage (RUC), septal cartilage (SC), Right lower lateralcartilage (RLC), and Left lower lateral cartilage (LLC), and Leftaccessory nasal cartilage (LANC).

FIG. 2 is a bottom plan view of the components of FIG. 1; In addition tothe labels above, the Medial Crus (MC) and Lateral Crus (LC) arelabeled, which together comprise the lateral cartilage. The Right Nose(RN) and Left nose (LN) are also labeled.

FIG. 3 is a right side elevation view of the components of FIG. 1; Inthis illustration, in addition to the labels above, the Right accessorynasal cartilage (RANC) is shown.

FIG. 4 is an oblique lateral view of the nasal structures. The nasaldorsum has both a bony and a cartilaginous component to give the nosethe lateral profile. The upper lateral cartilage (ULC), and lowerlateral cartilages (LLC) are labeled, and give the nose its structure.The Maxillary bone (MB) is the bone of the maxilla adjacent to the nose.The nasal shape and valve is also affected by the strength of theattachment of the lower lateral cartilage to the maxillary bone.

FIG. 5 is a bottom plan view of the nose showing the relation of thelower lateral cartilage (LLC) to the Medial cartilage (MC) and boththeir relationship to the nasal airway (NA). The Right nasal airway(RNA), and left nasal airway (LNA) are illustrated.

FIG. 6 is a cross sectional view of the nose. The Lateral cartilage (LC)refers to either the upper or lower lateral cartilage, depending on thearea of collapse. The Nasal valve angle (NVA) is the angle created bythe lateral cartilage and the septum (S). The lateral cartilage in thiscase is thinner, and weaker, and there is corresponding narrowing of thenasal airway (NA) due to collapse and narrowing of the nasal valve.

FIG. 7 is a cross sectional view of the nose after implantation of animplant (I). The Lateral cartilage (LC) is supported by the implant,(I). The Nasal valve angle (NVA) is thus supported from collapsingduring inspiration, widening the nasal airway (NA). In this case theimplant is implanted on the outer surface of the lateral cartilage andseptum (S).

FIG. 8 is an oblique lateral view of the nasal structures afterimplantation of an two implants acting as a batten grafts. The lowerlateral cartilages (LLC) and Maxillary bones (MB) are labeled. Theimplants (I1) and (I2) give support to the lateral edge of the lowerlateral cartilage, and strengthen its attachments to the maxillary bone.In this illustration, the implant I1 is situated medial to the lowerlateral cartilage, but overlying the maxillary bone, while implant I2 isplaced lateral to the lower lateral cartilage, and also lateral to themaxillary bone.

FIG. 9 is an oblique lateral view of the nasal structures afterimplantation of the proposed implants into other areas of the nose toachieve structural and cosmetic changes in the nose, not necessarilyrelated to the nasal valve. Some of the implant locations proposed hereand included for illustration purposes are: dorsal implants (DI), usedto modify the dorsal profile of the nose; Inferior Lower lateralcartilage Implant (ILLCI), which strengthens the lower lateral cartilageshape and form, thus also affecting the shape of the nose, and of thenasal tip; and Superior Lower Lateral Cartilage implant (SLLCI) alsoused to modify the shape of the lower lateral cartilage, and the nasalform; and a Collumella Implant (CI) used to give support to thecollumella.

FIG. 10 is an oblique lateral view of the nasal structures afterimplantation of the proposed implants into further areas of the nose toachieve structural and cosmetic changes in the nose. Shown here is animplant that is can be used as a Total Dorsal Profile Implant (TDPI),Paramedian Implants (PI), and Tip Implants (TI).

FIG. 11. The proposed modification to the nasal implant, where theimplant, (c), has attached to it a guiding needle, (a), a “pull through”suture, (b), and a trailing suture, (d).

FIG. 12. The introducing device composed of the implant (d) placed in anintroducing needle (e). There is the advancement shaft (c) which is usedto advance the implant (d), into the desired location. The stop (b)prevents the thumb control (a) and advancement shaft (c) from advancingafter the implant is expressed from the introducing needle, and placedin the desired location in the tissue. In the attachments FIGS. 12 A andB show an alternate arrangement in which the injector device (A) and theintroduction needle and implant (B) are packaged separately, but can beattached through a locking attachment (f).

FIG. 13 Representative shapes of the nasal implants. The implants ingeneral is elongated in shape having a length L and side profile P asshown in [FIG. 13 a]. The side profile may be oval in shape (FIG. 13 b),rectangular or oblong (FIG. 13 c), or have tapered at the ends (FIG. 13d). Furthermore, it may be a hollow cylinder, or made of two or morematerials (FIG. 13 e).

FIG. 14. The standard introduction method of the implant, in this caseimplanted into the lateral nose, to support the external nasal valve. InFIG. 14-1 the introduction needle containing the implant is firstintroduced through the nasal mucosa, and deep to the lower lateralcartilage. The introduction needle is then advanced into the desiredlocation for the implant (FIG. 14-2). The introduction needle is thenwithdrawn, as the implant is maintained in position by advancing theadvancement shaft (FIG. 14-3). After removal of the introduction needle,the implant is now present in the desired location (FIG. 14-4). Incertain situations, the implants shape may then be adjusted afterimplantation to assume the desired shape (FIG. 14-5).

FIG. 15 The introduction method using the additional introductionmodification shown in FIG. 11. In FIG. 15-1 through 15-3 The guidingneedle is first introduced and passed to along the path through whichthe implant will be placed. The “pull through” suture is then advanced.The implant is then advanced, usually with the guide of an introductionneedle system as shown in FIG. 15-4. The introduction needle is removedwhile the advancement shaft is advanced to maintain the implant in thedesired location (FIG. 15-5). The pull through and trailing sutures maythen used to finely adjust the position of the implant afterimplantation (FIG. 15-6). The sutures are then cut of at the skin ormucosal surface FIG. 15-7).

DESCRIPTION OF THE PREFERRED EMBODIMENT

Before the subject invention is described further, it is to beunderstood that the invention is not limited to the particularembodiments of the invention described below, as variations of theparticular embodiments may be made and still fall within the scope ofthe appended claims. It is also to be understood that the terminologyemployed is for the purpose of describing particular embodiments, and isnot intended to be limiting. Instead, the scope of the present inventionwill be established by the appended claims.

In this specification and the appended claims, the singular forms “a,”“an” and “the” include plural reference unless the context clearlydictates otherwise. Unless defined otherwise, all technical andscientific terms used herein have the same meaning as commonlyunderstood to one of ordinary skill in the art to which this inventionbelongs.

Where a range of values is provided, it is understood that eachintervening value, to the tenth of the unit of the lower limit unlessthe context clearly dictates otherwise, between the upper and lowerlimit of that range, and any other stated or intervening value in thatstated range, is encompassed within the invention. The upper and lowerlimits of these smaller ranges may independently be included in thesmaller ranges, and are also encompassed within the invention, subjectto any specifically excluded limit in the stated range. Where the statedrange includes one or both of the limits, ranges excluding either orboth of those included limits are also included in the invention.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood to one of ordinary skill inthe art to which this invention belongs. Although any methods, devicesand materials similar or equivalent to those described herein can beused in the practice or testing of the invention, the preferred methods,devices and materials are now described.

All publications mentioned herein are incorporated herein by referencefor the purpose of describing and disclosing the subject components ofthe invention that are described in the publications, which componentsmight be used in connection with the presently described invention.

The information provided below is not admitted to be prior art to thepresent invention, but is provided solely to assist the understanding ofthe reader.

The details of one or more embodiments of the invention are set forth inthe accompanying drawings and the description below. Other features,objects, and advantages of the invention will be apparent from thedescription and drawings, and from the claims.

The structure of the lower two thirds of the nose is determinedprimarily by the nasal septal cartilage, and paired upper and lowerlateral cartilages, covered by a soft tissue envelope [FIGS. 1-4].Structural weakness of these cartilages, or their attachments may resultin deleterious functional and cosmetic changes to the nose. The nasalvalves may collapse contributing to a dynamic nasal obstruction.Internal and external nasal valves exist.

The internal nasal valves are formed by the angle of the septum and thelower edge of the upper lateral cartilage [FIG. 5]. During inspiration,air flow creates a negative pressure on the cartilage, resulting in acollapse of the nasal walls, as seen in FIG. 6. This leads to nasalobstruction. In some cases there may also be collapse of the nasal valveat rest, resulting in a constricted airway even at rest which is furtherexacerbated with inspiration.

The external valve is formed by the shape of the lower lateralcartilage, and the strength of the attachments of these lower lateralcartilages to the lateral anterior maxillary bone. Weakening of thislateral cartilage also leads to airway obstruction which is exacerbatedwith inspiration.

Nasal patency is critical to the airway, and nasal obstruction cancontribute to snoring, sleep apnea, and disrupted sleep. The patency ofa good nasal airway is also critical for the growing number of peopleusing continuous positive airway pressure (CPAP) for sleep apnea.

Collapse and weakening of the nasal cartilage can also lead to externaldeformities and cosmetic changes to the nose. Loss of support and volumeof the lower lateral cartilages, mid-nasal portion or the dorsum canlead to undesirable cosmetic changes. Relative tissue defects on thedorsum of the nose may lead to an irregular nasal profile. Thesecosmetic differences have traditionally been addressed by surgicalrhinoplasty.

Common causes of nasal cartilage and nasal valve collapse today areprior surgery or trauma that weakens the cartilage, age, or congenitalweakness of the nasal cartilage.

Current therapies to correct nasal valve collapse include severalnon-surgical and surgical devices and techniques. Non-surgical devicesinclude external splints placed on the nasal surface which splay thelateral nasal walls outwardly, thus widening the nasal airway. Externalstrips are such an external device (U.S. Pat. Nos. 5,533,440, 6,238,411,6,982,359, 7,114,495). Other devices previously proposed include coneshaped applicators placed into the nostril, or dilators having a varietyof proposed shapes (U.S. Pat. Nos. 7,055,523, 6,978,781).

Surgical therapies for repair of the valve collapse include insertion ofspreader grafts (for internal valve collapse), batton grafts (forexternal valve collapse), or suspension sutures. These are placedthrough surgical incision techniques, or external rhinoplasty approach.The grafts are most commonly harvested from septal or auricularcartilage.

Implants (e.g., stents) made from alloplastic materials insertedsurgically through an external approach have also been described (U.S.Pat. Nos. 6,106,541, 6,454,803, 6,322,590, 2,173,848). These prevent themorbidity or limitations of homografts, but still require an incisionsurgical technique for placement.

Implants introduced through injection technique have been introducedinto the palate and used for the treatment of snoring and sleep apnea(U.S. Pat. No. 7,077,144).

With reference to the figures provided herewith, in which identicalelements are numbered identically throughout, a description of thepreferred embodiment of the present invention will now be provided.

A. Anatomy

Before proceeding with a description of the apparatus and method of thepresent invention, a review of relevant anatomy will facilitate anunderstanding of the present invention. FIGS. 1-3 show in perspective,bottom plan and right side elevation, respectively, components of thenose with skeletal muscle, soft tissue (such as external skin or nasalmucosa) and blood vessels removed.

The nose N includes nasal bone NB at an upper end of the nose. Thebottom of the nose N includes the lower cartilage also referred to asthe major alar cartilage. There is both a right lower cartilage RLC anda left lower cartilage LLC, which are generally symmetrical instructure.

The lower cartilages RLC, LLC include an external component referred toas the lateral crus LC and an internal component referred to as themedial crus MC. The medial crus and septal nasal cartilage create anasal septum NS divide the nose N into a left nostril LN and a rightnostril RN.

Upper cartilages reside between the lower cartilages and the nasal bonesNB. The upper cartilages include both a right upper cartilage RUC and aleft upper cartilage LUC separated by a septal cartilage SC extendingdown the bridge of the nose N. The opposing edges of the lower cartilageLLC, RLC and upper cartilage LUC, RUC may move relative to one another.Disposed between the opposing edges is an accessory nasal cartilage(left and right) LANC, RANC.

When congested, during inhalation, airflow through the nostrils createsan inward pressure at the junction between the upper and lowercartilages. This pressure is expressed as a function of nasal resistancewhich is estimated as 10 centimeters of water per one liter per second.Cole, “The Four Components of the Nasal Valve”, American Journal ofRhinology, pages 107-110 (2003).

In response to these forces, a weakened nasal valve may collapseinwardly as illustrated in FIG. 6. In FIG. 6, it will be appreciatedthat the inward deflection is exaggerated for ease of illustration. Itwill be noted with reference FIG. 5 that the narrow angle between theLLC and the MC illustrated in FIG. 6, and the relative weakness of theLLC contribute to the inward deflection and collapse of the airway.

B. Implant

1. The Implant:

The implant to be used in the present invention should be adapted fordeployment in a nose. Thereto, the implant should be adapted forintroduction into the nose of a patient, to be reliably positioned orinstalled within said nose and/or to be retained in said nose. Theadaptation may be such that the form (or shape) of the implant isadapted or preformed to the anatomy of the nose for which it isintended. For example, the location in the nose and the required effect(e.g. bulking only or stiffening) may dictate that different shapedimplants, or implants with different materials be used. The implant isself-holding when imbedded in the tissue.

Implants that can be used in the present invention include metallicimplants, polymeric implants, biodegradable implants and covered orcoated implants. They may be composed of a variety of metal compoundsand/or polymeric materials, fabricated in innumerable designs, composedof degradable and/or nondegradable components, fullyy or partiallycovered with raft materials (such as the so called “covered stents”) or“sleeves”, and can be bare metal or drug-eluting.

The implants may be comprised of a metal or metal alloy such asstainless steel, spring tempered stainless steel, stainless steelalloys, gold, platinum, super elastic alloys, cobalt-chromium alloys andother cobalt-containing alloys (including ELGILOY (Combined Metals ofChicago, Grove Village, Ill.), PHYNOX (Alloy Wire International, UnitedKingdom) and CONICHROME (Carpenter Technology Corporation, Wyomissing,Pa.)), titanium-containing alloys, platinum-tungsten alloys,nickel-containing alloys, nickel-titanium alloys (including nitinol),malleable metals (including tantalum); a composite material or a cladcomposite material and/or other functionally equivalent materials;and/or a polymeric (non-biodegradable or biodegradable) material.Representative examples of polymers that may be included in the implantconstruction include polyethylene, polypropylene, polyurethanes,polyesters, such as polyethylene terephthalate (e.g. DACRON or MYLAR(E.I. DuPont De Nemours and Company, Wilmington, Del.)), polyanides,polyaramids (e.g., KEVLAR from E.I. DuPont De Nemours and Company),polyfluorocarbons such as poly(tetrafluoroethylene with and withoutcopolymerized hexafluoropropylene) (available, e.g., under the tradename TEFLON (E.I. DuPont De Nemours and Company), silk, as well as themixtures, blends and copolymers of these polymers. Stents also may bemade with engineering plastics, such as thermotropic liquid crystalpolymers (LCP), such as those formed fromp,p′-dihydroxy-polynuclear-aromatics or dicarboxy-polynuclear-aromatics.

Further types of implants (e.g., stents) that can be used with thedescribed therapeutic agents are described, e.g., in PCT Publication No.WO 01/01957 and U.S. Pat. Nos. 6,165,210; 6,099,561; 6,071,305;6,063,101; 5,997,468; 5,980,551; 5,980,566; 5,972,027; 5,968,092;5,951,586; 5,893,840; 5,891,108; 5,851,231; 5,843,172; 5,837,008;5,766,237; 5,769,883; 5,735,811; 5,700,286; 5,683,448; 5,679,400;5,665,115; 5,649,977; 5,637,113; 5,591,227; 5,551,954; 5,545,208;5,500,013; 5,464,450; 5,419,760; 5,411,550; 5,342,348; 5,286,254; and5,163,952. Removable drug-eluting stents are described, e.g., inLambert, T. (1993) J. Am. Coll. Cardiol.: 21: 483A. Moreover, the stentmay be adapted to release the desired agent at only the distal ends, oralong the entire body of the stent.

In addition to using the more traditional stents, stents that arespecifically designed for drug delivery can be used. Examples of thesespecialized drug delivery stents as well as traditional stents includethose from Conor Medsystems (Palo Alto, Calif.) (e.g., U.S. Pat. Nos.6,527,799; 6,293,967; 6,290,673; 6,241,762; U.S. Patent ApplicationPublication Nos. 2003/0199970 and 2003/0167085; and PCT Publication No.WO 03/015664).

Other examples of stents that can be used in accordance with theinvention include those from Boston Scientific Corporation, (e.g., thedrug-eluting TAXUS EXPRESS² Paclitaxel-Eluting Coronary Stent System;over the wire stent stents such as the Express² Coronary Stent Systemand NIR Elite OTW Stent System; rapid exchange stents such as theEXPRESS² Coronary Stent System and the NIR ELITE MONORAIL Stent System;and self-expanding stents such as the MAGIC WALLSTENT Stent System andRADIUS Self Expanding Stent); Medtronic, Inc. (Minneapolis, Minn.)(e.g., DRIVER ABT578-eluting stent, DRIVER ZIPPER MX Multi-ExchangeCoronary Stent System and the DRIVER Over-the-Wire Coronary StentSystem; the S7 ZIPPER MX Multi-Exchange Coronary Stent System; S7, S670,S660, and BESTENT2 with Discrete Technology Over-the-Wire Coronary StentSystem); Guidant Corporation (e.g., cobalt chromium stents such as theMULTI-LINK VISION Coronary Stent System; MULTI-LINK ZETA Coronary StentSystem; MULTI-LINK PIXEL Coronary Stent System; MULTI-LINK ULTRACoronary Stent System; and the MULTI-LINK FRONTIER); Johnson &Johnson/Cordis Corporation (e.g., CYPHER sirolimus-eluting Stent;PALMAZ-SCHATZ Balloon Expandable Stent; and S.M.A.R.T. Stents); AbbottVascular (Redwood City, Calif.) (e.g., MATRIX LO Stent; TRIMAXX Stent;and DEXAMET stent); Conor Medsystems (Menlo Park, Calif.) (e.g.,MEDSTENT and COSTAR stent); AMG GmbH (Germany) (e.g., PICO Elite stent);Biosensors International (Singapore) (e.g., MATRIX stent, CHAMPION Stent(formerly the S-STENT), and CHALLENGE Stent); Biotronik (Switzerland)(e.g., MAGIC AMS stent); Clearstream Technologies (Ireland) (e.g.,CLEARFLEX stent); Cook Inc. (Bloomington, Ind.) (e.g., V-FLEX PLUSstent, ZILVER PTX self-expanding vascular stent coating, LOGIX PTX stent(in development); Devax (e.g., AXXESS stent) (Irvine, Calif.); DISAVascular (Pty) Ltd (South Africa) (e.g., CHROMOFLEX Stent, S-FLEX Stent,S-FLEX Micro Stent, and TAXOCHROME DES); Intek Technology (Baar.Switzerland) (e.g., APOLLO stent); Orbus Medical Technologies(Hoevelaken, The Netherlands) (e.g., GENOUS); Sorin Biomedica (Saluggia,Italy) (e.g., JANUS and CARBOSTENT); and stents from Bard/Angiomed GmbHMedizintechnik KG (Murray Hill, N.J.), and Blue Medical Supply &Equipment (Marietta, Ga.). Aachen Resonance GmbH (Germany); Eucatech AG(Germany), Eurocor GmbH (Bonn, Gemany), Prot, Goodman, Terumo (Japan).Translumina GmbH (Germany), MIV Therapeutics (Canada), OccamInternational B.V. (Eindhoven, The Netherlands), Sahajanand MedicalTechnologies PVT LTD. (India); AVI Biopharma/Medtronic/InterventionalTechnologies (Portland, Oreg.) (e.g., RESTEN NG-coated stent); andJoined (e.g., FLEXMASTER drug-eluting stent) (Sweden). Other types ofstents can be in US20060147492A1: Medical implants and anti-scarringagents. The entire content of US20060147492A1 is incoportated herein byreference.

Generally, the implants are inserted in a similar fashion regardless ofthe site or the disease being treated. Briefly, a preinsertionexamination is conducted by direct visualization, possible endoscopy,and rarely diagnostic imaging. The areas of structural defects, volumedefects, of dynamic collapse of the nose are noted. The implant size andmaterial is selected to suit the particular application, where more thanone implant material and size may be available.

Topical local anesthetic may be applied by a combination of topicalanesthetic cream applied to the skin (e.g. 4% lidocaine cream availablecommercially) and/or topical anesthetic solution (e.g 4% lidocainesolution) applied on a cotton pledget in the nasal cavity. Localanesthetic may be infiltrated directly in the area where the implantwill be placed, or also injected to perform regional blocks, such as aninfraorbital nerve block.

The implant is then introduced through an injection technique asillustrated in this patent (for example, see FIG. 14). The implant isintroduced through the injection method into the desired location in thenasal tissues. The introducing needle is gradually withdrawn, while theimplant is maintained in its desired position by means of theadvancement shaft of the introduction device. Generally, the puncturesite performed by the introduction needle is small, and does not requirerepair.

After insertion, the implant shape may be adjusted manually. In somesituations a special condition is applied to allow for adjustment of theshape of the implant. For example, in the case of an implant withcertain physical properties, heat may be applied by external applicationof a heating pad to the nose. This is transmitted through the tissue tothe implant which raises its temperature. The shape of the implant isthen adjusted to the desired shape, and the external heat source isremoved. The implant then maintains this new shape as it is cools.

A post insertion examination, is performed to visually confirm that thedesired structural and shape change to the nose has been achieved.Rarely, diagnostic imaging or endoscopy may also be used at this stage.

Implants are typically maneuvered into place directed by visual andtactile control. In certain aspects, the implant (e.g., stent) canfurther include a radio-opaque, echogenic material, or MRI responsivematerial (e.g., MRI contrast agent) to aid in visualization of thedevice under ultrasound, fluoroscopy and/or magnetic resonance imaging.The radio-opaque or MRI visible material may be in the form of one ormore markers (e.g., bands of material that are disposed on either end ofthe implant).

As suitable implant materials, both organic and inorganic materials, aswell as combinations thereof may be used. The material of the inplantmay be solid, (e.g. titanium, nitinol, or Gore-tex), braided or wovenfrom a single material (such as titanium, or Polyethylene Terephthalate,or a combination of materials). The woven materials may have pores whichallow ingrowth of tissue after implantation. It may be manufactured frombiodegradable materials (e.g poly-L lactic, Poly-D lactic, and poly-Lglycolic acid) which will gradually absorb after implantation. It may bemalleable, allowing adjustment of the shape before, or afterimplantation.

Synthetic polymers provide for very suitable organic implant (e.g.,stent) materials. Advantages of such polymers include the ability totailor mechanical properties and degradation kinetics to suit variousapplications. Synthetic polymers are also attractive because they can befabricated into various shapes. Numerous synthetic polymers can be usedto prepare synthetic polymer-comprising stents useful in aspects of theinvention. They may be obtained from sources such as Sigma Chemical Co.,St. Louis, Mo., Polysciences, Warrenton. Pa., Aldrich, Milwaukee, Wis.,Fluka, Ronkonkoma, N.Y., and BioRad, Richmond, Calif.

Representative synthetic polymers include alkyl cellulose, celluloseesters, cellulose ethers, hydroxyalkyl celluloses, nitrocelluloses,polyalkylene glycols, polyalkylene oxides, polyalkylene terephthalates,polyalkylenes, polyamides, polyaiihydrides, polycarbonates, polyesters,polyglycolides, polymers of acrylic and methacrylic esters,polyacrylamides, polyorthoesters, polyphe azenes, polysiloxanes,polyurethanes, polyvinyl ohols, polyvinyl esters, polyvinyl ethers,polyvinyl halides, polyvinylpyrrolidone, poly(ether ether ketone)s,silicone-based polymers and blends and copolymers of the above. Thestent may comprise both oligomers and polymers of the above.

Specific examples of these broad classes of polymers include poly(methylmethacrylate), poly(ethyl methacrylate), poly(butyl methacrylate),poly(isobutyl methacrylate), poly(hexyl methacrylate), poly(isodecylmethacrylate), poly(lauryl methacrylate), poly(phenyl methacrylate),poly(methyl acrylate), poly(isopropyl acrylate), poly(isobutylacrylate), poly(octadecyl acrylate), polyethylene, polypropylene,poly(ethylene glycol), poly(ethylene oxide), poly(ethyleneterephthalate), poly(vinyl alcohols), poly(vinyl acetate), poly(vinylchloride), polystyrene, polyurethane, poly(lactic acid), poly(butyricacid), poly(valeric acid), poly[lactide-co-glycolide], poly(fumaricacid), poly(maleic acid), copolymers of poly (caprolactone) or poly(lactic acid) with polyethylene glycol and blends thereof.

The polymers used in implants (e.g., stents) may be non-biodegradable.Examples of preferred non-biodegradable polymers include ethylene vinylacetate (EVA), poly(meth)acrylic acid, polyamides, silicone-basedpolymers and copolymers and mixtures thereof.

Polymers used in implants (e.g., stents) may also be biodegradable. Therate of degradation of the biodegradable stent is determined by factorssuch as configurational structure, copolymer ratio, crystallinity,molecular weight, morphology, stresses, amount of residual monomer,porosity and site of implantation. The skilled person will be able tochoose the combination of factors and characteristics such that the rateof degradation is optimized.

Examples of preferred biodegradable polymers include synthetic polymerssuch as polyesters, polyanhydrides, poly(ortho)esters, polyurethanes,siloxane-based polyurethanes, poly(butyric acid), tyrosine-basedpolycarbonates, and natural polymers and polymers derived therefrom suchas albumin, alginate, casein, chitin, ch[embedded image not shown]osan,collagen, dextran, elastin, proteoglycans, gelati[embedded image notshown] and other hydrophilic proteins, glutin, zein and other prolaminesand hydrophobic proteins, starch and other polysaccharides includingcellulose and derivatives thereof (e.g. methyl cellulose, ethylcellulose, hydroxypropyl cellulose, hydroxy-propyl methyl cellulose,hydroxybutyl methyl cellulose, carboxymethyl cellulose, celluloseacetate, cellulose propionate, cellulose acetate butyrate, celluloseacetate phthalate, cellulose acetate succinate,hydroxypropylmethylcellulose phthalate, cellulose triacetate, cellulosesulphate), poly-1-lysine, polyethylenimine, poly(allyl amine),polyhyaluronic acids, and combinations, copolymers, mixtures andchemical derivatives thereof (substitutions, additions of chemicalgroups, for example, alkyl, alkylene, hydroxylations, oxidations, andother modifications routinely made by those skilled in the art). Ingeneral, these materials degrade either by enzymatic hydrolysis orexposure to water in vivo, by surface or bulk erosion. The foregoingmaterials may be used alone, as physical mixtures (blends), or as aco-polymer.

Other polymers are polyesters, polyanhydrides, polystyrenes and blendsthereof. The polyesters and polyanhydrides are advantageous due to theirease of degradation by hydrolysis of ester linkage, degradation productsbeing resorbed through the metabolic pathways of the body in some casesand because of their potential to tailor the structure to alterdegradation rates. The mechanical properties of the biodegradablematerial are preferably selected such that early degradation andconcomitant loss of mechanical strength required for it's functioning asa structure supporting implant is prevented.

Biodegradable polyesters are for instance poly(glycolic acid) (PGA),poly(lactic acid) (PLA), poly(glycolic-co-lactic acid) (PGLA),poly(dioxanone), poly(caprolactone) (PCL), poly(3-hydroxybutyrate)(PHB), poly(3-hydroxyvalerate) (PHV), poly(lactide-co-caprolactone)(PLCL), poly(valerolactone) (PVL), poly(tartronic acid), poly(β-malonicacid), poly(propylene fumarate) (PPF) (preferably photo cross-linkable),poly(ethylene glycol)/poly(lactic acid) (PELA) block copolymer,poly(L-lactic acid-e-caprolactone) copolymer, andpoly(lactide)-poly(ethylene glycol) copolymers.

Biodegradable polyanhydrides are for instancepoly[1,6-bis(carboxyphenoxy)hexane], poly(fumaric-co-sebacic)acid orP(FA:SA), and such polyanhydrides may be used in the form of copolymerswith polyimides or poly(anfydrides-co-imides) such aspoly-[trimellitylimidoglycine-co-bis(carboxyphenoxyl)hexane],poly[pyromellitylimidoalanine-co-1,6-bis(carboph-enoxy)-hexane],poly[sebacic acid-co-1,6-bis(p-carboxyphenoxy)hexane] or P(SA:CPH) andpoly[sebacic acid-co-1,3-bis(p-carboxyphenoxy)propane] or P(SA:CPP).

Other suitable stent materials are biocompatible materials that areaccepted by the tissue surface. The broad term biocompatible includesalso nontoxicity, noncarcinogenity, chemical inertness, and stability ofthe material in the living body. Exemplary biocompatible materials aretitaniun, alumina, zirconia, stainless steel, cobalt and alloys thereofand ceramic materials derived therefrom such as ZrO2 and/or Al2O3.

As examples of inorganic implants (e.g., stents) materials calciumphosphate matrices (CaP) and hydroxyapatite (HA) matrices may be used,wherein HA may optionally be combined with tricalcium phosphate to formsuch compounds as biphasic calcium phosphate (BCP). CaP, sinteredhydroxyapatite and bioactive glasses or ceramics, such as 45S5 Bioglass®(US Biomaterials Corp, USA), and apatite- and wollastonite-containingglass-ceramic (glass-ceramic A-W) may also be used. Very suitable matrixmaterials are the combined materials such as osteoinductivehydroxyapatite/(HA/TCP) matrices, preferably BCP.

One form of the nasal implant described here is introduced through aninjection device. The implant (A) is elongated in shape having a lengthL and side profile P [FIG. 13 a]. The side profile may be oval in shape,rectangular, or tapered at the ends [FIGS. 13 (b, c, and d)].Furthermore, it may be a hollow cylinder (FIG. 13 e), or made of acomposite of materials, or a braid of wires. They are introduced intothe nose non-surgically through an injection device. The injection routemay include transcutaneous route, i.e. through the nasal skin, ortransmucossally, through the internal mucosa of the nose. The intentionof this device is that it be introduced under local anesthetic.

The nasal implant may also incorporate an introduction needle andsuture, and/or a trailing suture (FIG. 11). This provides an alternativemethod for introduction of the implant. The guiding needle is introducedthrough the skin, or mucosa, and tracked along the desired path to thelocation choosen for the implant and then to a location where it exitsthe body, such as through the skin. This guiding needle is introducedand guided by the physicians fingers, or using standard medicalinstruments. This method for introduction of the implant which includesa “pull through” and trailing sutures is illustrated in FIG. 15. Afterintroduction of the “pull through” suture shown in FIG. 15, the guidingneedle may be cut off. The implant is then introduced with the injectiondevice in FIG. 12, with the guidance of the “pull through” suture, asillustrated in FIG. 15. Alternatively, it may be introduced without aninjection device, but simply by guiding it to the desired location bygently pulling on the “pull through” suture. The trailing suture canalso be used to make adjustments to the position of the implant in situ.When the desired position is accomplished, the pull through suture, andthe trailing sutures are cut. The suture can be made of absorbablematerial. The suture may have a diameter similar to the diameter of theimplant, or be smaller or larger.

The injector device allows the introduction of the implant into the bodythrough an injection technique. Shown in FIG. 12, it incorporates thenasal implant (FIG. 14-d), an introducing needle (FIG. 14-e). Theimplants are introduced through an injection device either through thetranscutaneous route or through the nasal mucosa. The implant is placedthrough a straight introducer device, or a specially curved introducerdevice, or may be malleable to allow for special shaping of the needleprior to injection.

These implants may be placed adjacent to the upper lateral cartilage,below the nasal surface, as illustrated in FIG. 7. This will applylateral force to the medial portion of the lateral nasal cartilage,stenting the internal nasal valves open. This is an alternative to thespreader grafts currently placed surgically.

The implants may be placed adjacent to the lateral edge of the lowerlateral cartilages. The implants may extend to the bony process of theanterior maxillary bone as illustrated in FIG. 8. This will secure thelateral cartilage more securely to the maxillary bone, preventinglateral nasal collapse. These implants may be placed to secure theexternal valve in place of alar batten grafts that are now employed andare applied surgically. They may be inserted overlying or underlying thelateral surface of the lower lateral cartilage.

The implants may have a straight or curved shape. Alternately, they mayhave a malleable property, and can have the shape adjusted afterimplantation. They may also have shape memory properties (such ascomposed of Nitinol) which allows for their shape to assume apredetermined shape after implantation. Use of inserts made of materialswhich have shape memory properties permit the implant to assume a presetshape after insertion. Alternately, certain conditions may be applied,such as application of heat, cold, light, or a magnetic field, that willallow the material to assume a desired fixed or modified shape afterimplantation. The necessary condition will depend on the intrinsicproperties of the shape memory material chosen to produce the implant.The fixed shape of the implant may also be adjusted before or afterinsertion. The implant may be composed of biodegradable materials, withor without shape memory.

Another aspect of this invention provides for the use of the describedinjectable implants for cosmetic changes to the nose. The implants maybe introduced transcutaneously or transmucosally to improve thestructural strength of the nasal cartilages, or to fill defects in thenasal contours. Examples of proposed areas where the implants can beplaced include locations adjacent to the lower lateral cartilage aslateral alar implants, in the mid nasal region, and the nasal dorsum, orthe collumella, as illustrated in FIG. 9, and FIG. 10.

EXAMPLES

Three working examples of useful implants have been produced forinsertion into the nose.

The first is a 1.4 cm long, 0.8 mm thick titanium rod that isincorporated in a 16 gauge injection needle. This is designed for useinto the lateral nasal wall which supports the external valve. Theimplant is injected in a fashion similar to the technique illustrated inFIG. 14. The currently preferred method of introduction is transmucosaly(from inside the vestibule of the nose). The implant is placed betweenthe lower lateral cartilage and the nasal mucosa, and extends over themaxillary bone. When placed, it appears similar to the implant I1 shownin FIG. 8. One implant is placed for each side of the nose, if bilateralvalve collapse is present. After implantation, the shape of the implantcan be adjusted by molding the shape of the titanium implant.

In another example, a 1.8 cm long and 1 mm thick rod manufactured from a85:15 poly (L-lactide-co-glycolide) polymer has been produced. It isintroduced using a 14 gauge needle. This polymer is bio-absorbable. Itis inserted transcutaneously over the medial portion of the nose,similar to the one shown in FIG. 7. After implantation, the material hassome structural strength, and by providing an upward force on the medialportion of the upper lateral cartilage, it supports the internal nasalvalve, preventing its collapse. The shape of the implant can be adjustedafter implantation by temporarily placing a heating pad at 64 degreesCelsius on the surface of the nose. This temperature is tolerated by thehuman nose for a brief period of time. The temperature is transmitted tothe implant, and at such a temperature the polymer softens, and theimplant shape can manually adjusted. The implant retains the new shapeas it cools.

The third example used is a tapered rod with an oval shaped crosssection similar to the implant shown in FIG. 13 b. The implantdimensions may be trimmed prior to implantation depending on theparticular size desired for the particular patient to be implanted. Thisimplant is manufactured from a porous polyethylene. It is inert,non-absorbable, and has a porous structural surface which allows forfibrovascular tissue ingrowth. It is introduced through a 14 gaugeneedle, into the dorsum of the nose, filling in volume defects in thenose. This is similar to the DI implant shown FIG. 9.

Unless otherwise defined, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art of molecular biology. Although methods and materials similar orequivalent to those described herein can be used in the practice ortesting of the present invention, suitable methods and materials aredescribed herein. All publications, patent applications, patents, andother references mentioned herein are incorporated by reference in theirentirety. In case of conflict, the present specification, includingdefinitions, will control. In addition, the materials, methods, andexamples are illustrative only and are not intended to be limiting.

EQUIVALENTS

Those skilled in the art will recognize, or be able to ascertain usingno more than routine experimentation, many equivalents to the specificembodiments of the invention described herein. Such equivalents areintended to be encompassed by the following claims.

1. A method for non-surgically treating an nasal valve of a patientcomprising, injecting a working device into the nasal and/or paranasaltissues of the patient, wherein the injected working device causes analteration of an internal nasal valve.
 2. The method of claim 1, whereinthe alteration of an internal nasal valve results in a change in theinternal nasal valve angle.
 3. The method of claim 2, wherein thealteration of an internal nasal valve angle results in a 10-15 degreeinternal nasal valve angle.
 4. The method of claim 1, wherein theworking device is injected into a junction of an upper lateral cartilageportion and a septum cartilage portion of the internal nasal valve. 5.The method of claim 4, wherein the alteration of an internal nasal valveangle is effected by the biomaterial filler displacing the upper lateralcartilage portion laterally away from the septal cartilage portion ofthe internal nasal valve.
 6. The method of claim 1, wherein injectingthe working device is for treatment of nasal and/or paranasal tissues ofthe patient.
 7. The method of claim 1, wherein injecting working deviceis for treatment of sleep apnea.
 8. The method of claim 1, whereinworking device is for treatment of nasal snoring.
 9. The method of claim1, wherein working device is used in the treatment of cosmetic changes.10. The method of claim 1, wherein the working device is an implant. 11.The method of claim 10, wherein the implant is a nasal implant.
 12. Themethod of claim 10, wherein the implant is a stent.
 13. The method ofclaim 12, wherein the implant is a nasal stent.
 14. The method of claim1, wherein the working device has shape memory properties.
 15. Themethod of claim 1, wherein the working device has moldability properties16. The method of claim 1, wherein the working device may be moldablebefore or after implantation
 17. The method of claim 1, wherein theworking device may be absorbable.
 18. The method of claim 1, wherein theworking device has a shape adjusted with application of a physicalcondition, (e.g temperature) after implantation.
 19. The method of claim1, wherein the working device has shape revert to preselected shape. 20.The method of claim 1, wherein the working device has shape revert topreselected shape, wherein the preselected shape is a shape memory. 21.The method of claim 1, wherein the working device comprises a suture.22. A method for minimally invasive treating an internal nasal valve ofa patient comprising, injecting a working device into the internal nasalvalve of the patient, wherein the injected working device in theinternal nasal valve causes an alteration of an internal nasal valveangle.
 23. A method for non-surgically treating disorder affecting thenose in a human subject, said method comprising the steps of: a.providing an introducing working device that has a proximal end and adistal end; b. advancing the introducing device through the nose; c.providing a working device that is positionable in an operative locationand useable to perform a therapeutic procedure within the opening of thenose; d. using the introducing device to facilitate advancement of theworking device to the operative location; and e. using the workingdevice to perform a therapeutic procedure within the nose.
 24. Themethod of claim 1, wherein the nasal and/or paranasal tissues contains acollapse in the internal nasal valve.
 25. A method for non-surgicallytreating an internal or an external nasal valve of a patient comprising,injecting a working device into the nasal and/or paranasal tissues ofthe patient, wherein the injected working device causes an alteration ofan internal or an external part(s) of the nasal valve.